510(k) K042376 ยท DYB Introducer, Catheter
ACUMEN SHEATH, MODEL TTW7807
| Applicant | Acumen Medical, Inc., Mountain View CA, US |
| Decision | Substantially Equivalent, Oct 26, 2004 |
| Received | Sep 1, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042376
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.